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Rehabilitation After Fast-track Total Knee Arthroplasty (HOLEST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Aarhus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01329081
First received: April 27, 2010
Last updated: April 4, 2011
Last verified: April 2011
  Purpose

BACKGROUND In 2008 approximately 7,700 total knee arthroplasties (TKA) were performed in Denmark. The results after TKA is in general very good, the investigators have, however, discovered that patients following fast-track TKA still have a deficit 12 months postoperatively of 5-10% in health-related quality-of-life and 15-20% in activity and participation when compared to age- and gender matched population. A postoperative rehabilitation intervention has the potential to reduce or remove this observed deficit. The current evidence of postoperative rehabilitation after TKA is, however, scares and conflicting, and no studies have shown a lasting effect beyond 3 months postoperatively.

PURPOSE The purpose of this study is to investigate if a 6-weeks postoperative rehabilitation intervention is more effective than supervised home training, and furthermore to investigate the cost-effectiveness of the intervention in a societal perspective.

MATERIALS & METHODS The study is performed as a randomized clinical trial. In total 140 patients are included in the study. Inclusion criteria are age above 18 years, patients diagnosed as having knee arthrosis, patients receiving primary elective TKA, and patients who are able to and willing transport themselves to the rehabilitation center, which demands ability to walk 50 meter, and climb 10 stair steps. Exclusion criteria are unicompartmental or revision arthroplasty, any neurological disease, knee infection, and substantial pain or functional limitation hindering rehabilitation tested by physiotherapist prior to rehabilitation start. Primary endpoint is 6 months postoperatively and primary outcome measure is change in total score by using the knee specific questionnaire Oxford Knee Score.


Condition Intervention
Knee Arthroplasty
Other: Postoperative rehabilitation after fast-track TKA

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rehabilitation After Fast-track Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Oxford Knee Score [ Time Frame: Six months postoperatively ] [ Designated as safety issue: No ]
    A disease specific questionnaire, which measures knee pain and function with 12 items. The questionnaire is sum scored with a range from 0 = worse pain and function to 48 = best pain and function


Secondary Outcome Measures:
  • EQ-5D [ Time Frame: Twelve months postoperatively ] [ Designated as safety issue: No ]
    A generic questionnaire, which measures health-related quality-of-life (HRQOL) with 5 items. The questionnaire is scored with a range from -0.55 = worse HRQOL to 1.00 = best HRQOL


Estimated Enrollment: 140
Study Start Date: April 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Six weeks strength training in teams and patient education Other: Postoperative rehabilitation after fast-track TKA
Six weeks of strength training combined with patient education
Other Names:
  • Rehabilitation
  • Strength
  • Patient education
Experimental: Supervised home training with focus on activities Other: Postoperative rehabilitation after fast-track TKA
Six to eight weeks of supervised home training

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age above 18 years
  • patients diagnosed as having knee arthrosis
  • patients receiving primary elective TKA and
  • patients who are able to and willing transport themselves to the rehabilitation center, which demands ability to walk 50 meter, and climb 10 stair steps

Exclusion Criteria:

  • unicompartmental or revision arthroplasty
  • any neurological disease
  • knee infection and
  • substantial pain or functional limitation hindering rehabilitation tested by physiotherapist prior to rehabilitation start
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329081

Contacts
Contact: Kristian Larsen, Ph.D. 99125358 ext 45 kristian.larsen@svf.au.dk

Locations
Denmark
Orthopedic Research Unit, Hospital Unit West Recruiting
Holstebro, Denmark, 7500
Contact: Kristian Larsen, Ph.D.    99125358 ext 45    kristian.larsen@svf.au.dk   
Principal Investigator: Kristian Larsen, Ph.D.         
Sub-Investigator: Hanne Søe, Physiotherapist         
Sub-Investigator: Inger K Madsen, Physiotherapist         
Sub-Investigator: Lars Rasmussen, MSc         
Sub-Investigator: Torben B Hansen, Ph.D.         
Sub-Investigator: Kjeld Søballe, MD, Professor         
Sub-Investigator: Henrik Kehlet, Ph.D.         
Sponsors and Collaborators
University of Aarhus
  More Information

No publications provided

Responsible Party: Kristian Larsen, Ph.D., Associate Professor, Principal Investigator, Orthopedic Research Unit, Hospital Unit West, Denmark
ClinicalTrials.gov Identifier: NCT01329081     History of Changes
Other Study ID Numbers: KL24621
Study First Received: April 27, 2010
Last Updated: April 4, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Rehabilitation
Strength training
Long-term effect
Activity and participation after fast-track knee arthroplasty

ClinicalTrials.gov processed this record on November 20, 2014